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Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study

Primary Purpose

the Efficacy of Ultrasound Guided Sacroiliac Injection of Ozone, Platelet Rich Plasma (PRP) or Steroid for Treatment of Sacroiliitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
methylprednisolone acetate and lidocaine
PRP and lidocaine
medical ozone
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for the Efficacy of Ultrasound Guided Sacroiliac Injection of Ozone, Platelet Rich Plasma (PRP) or Steroid for Treatment of Sacroiliitis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis. Exclusion Criteria: • Patient refusal Psychological disturbance. Local skin infection at the site of injection. Ozone allergy Coagulation disorders. Chronic opioid use. Sacroiliitis associated with disk pathology. Severe ankylosing spondylitis. History of corticosteroid injection within last three months. Uncontrolled concomitant medical condition. Severe arrhythmia, hypertensive crisis and other cardiovascular diseases. Pregnant women. Bowel inflammatory disease. Psoriasis

Sites / Locations

  • Tanta University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection

3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks

10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks

Outcomes

Primary Outcome Measures

Assessment of pain intensity using visual analog scale (VAS)
Primary outcome

Secondary Outcome Measures

Full Information

First Posted
May 31, 2023
Last Updated
June 21, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05914350
Brief Title
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
Official Title
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Anticipated)
Primary Completion Date
March 23, 2025 (Anticipated)
Study Completion Date
March 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study
Detailed Description
The sacroiliac joints (SIJ) are the largest axial joints in the human body. By aging, osteoarthritic degeneration occurs to SIJ. SIJ dysfunction typically results from abnormal motion and malalignment of the joint (1). SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4). SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5). Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6). Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8). Another treatment modality is Platelet-rich plasma (PRP) which is autologous blood that contains platelet concentrations above normal physiological levels (9). PRP is believed to stimulate regeneration through the release of growth factors and proteins that may be involved in repairing the degeneration (10, 11). While corticostroid injection has rapid onset of pain releif with short duration, the PRP injection has delayed onset and long term of pain releif in recent studies (12-14). Ozone therapy has been used in the treatment of many musculoskeletal diseases including low back pain (LBP), lumbar disk herniation, cervical pain, cervical disk herniation, failed back surgery syndrome, degenerative spinal disease, knee osteoarthritis, meniscal injuries, sacroiliitis, plantar fasciitis and carpal tunnel syndrome (8, 15). However, ozone therapy is not tested well in SIJ. Ozone has multiple mechanisms of action:, antioxidant, analgesic and antiinflammatory effects (16, 17). Ultrasound has gained increasing popularity in pain management (18). Furthermore, it is a valuable tool for pain physicians in confirming the diagnosis of many musculoskeletal pain conditions (19). It has many advantages when compared to fluoroscopy techniques (20). It has no radiation exposure, procedures can be done outside operating room which will decrease the costs (21).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Efficacy of Ultrasound Guided Sacroiliac Injection of Ozone, Platelet Rich Plasma (PRP) or Steroid for Treatment of Sacroiliitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection
Arm Title
Group 2
Arm Type
Experimental
Arm Description
3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
Arm Title
Group 3
Arm Type
Experimental
Arm Description
10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
Intervention Description
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
Intervention Type
Drug
Intervention Name(s)
methylprednisolone acetate and lidocaine
Intervention Description
40 mg methylprednisolone acetate and 1 mL lidocaine
Intervention Type
Drug
Intervention Name(s)
PRP and lidocaine
Intervention Description
3 mL PRP and 1 mL lidocaine
Intervention Type
Drug
Intervention Name(s)
medical ozone
Intervention Description
10 ml of medical ozone
Primary Outcome Measure Information:
Title
Assessment of pain intensity using visual analog scale (VAS)
Description
Primary outcome
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis. Exclusion Criteria: • Patient refusal Psychological disturbance. Local skin infection at the site of injection. Ozone allergy Coagulation disorders. Chronic opioid use. Sacroiliitis associated with disk pathology. Severe ankylosing spondylitis. History of corticosteroid injection within last three months. Uncontrolled concomitant medical condition. Severe arrhythmia, hypertensive crisis and other cardiovascular diseases. Pregnant women. Bowel inflammatory disease. Psoriasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed An Ibrahim
Phone
01092939382
Email
amer.soliman0@gmail.com
Facility Information:
Facility Name
Tanta University hospitals
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Ab Ibrahim
Phone
01092939382
Email
amer.soliman0@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study

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